Tennessee Reaches Settlement with Wyeth over Allegations of Off Label Marketing of Kidney Transplant Drug

August 1, 2013, #13-18

Tennessee will receive $768,890 as its share of a multimillion dollar settlement Wyeth Pharmaceuticals, Inc. (Wyeth) reached with other states and the federal government to resolve allegations of off label marketing of Rapamune, Tennessee Attorney General Bob Cooper announced today.

Wyeth was named in civil and criminal proceedings for allegedly illegally promoting the sale and use of the kidney transplant drug Rapamune for use in connection with solid organ transplant patients other than kidney patients. Rapamune is FDA approved to prevent the body from rejecting a donor kidney that has been transplanted into the body.

The investigation resulted from whistleblower actions filed under the federal False Claims Act and various state false claims statutes.

Wyeth has agreed to pay the states and the federal government $257,400,000 in civil damages and penalties to resolve the civil allegations of off label marketing of Rapamune. Furthermore, Wyeth has pled guilty in federal court in Oklahoma to violations of the U.S. Food, Drug, and Cosmetic Act, and has agreed to pay $233,600,000 in criminal fines and forfeitures.

"We all pay when drug companies ignore laws and potentially trade safety for profit," Attorney General Cooper said. "We are grateful for those who came forward to report this unlawful activity."

In late 2009 Pfizer Inc. (a Delaware corporation headquartered in New York City) acquired Wyeth. The off label marketing, and the conduct to which Wyeth pled guilty, occurred prior to Pfizer's acquisition of Wyeth. Pfizer cooperated fully with the federal government and the states in the investigation.